MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 12 MM THICKNESS; PROSTHESIS, KNEE

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The returned item exhibit signs of repeated use and has one of components 42527991001 and 42527991002 disassembled / missing.The components were not returned.The dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported a tasp was returned missing a bearing on a worn instrument claim form.This was discovered at the warehouse were trays are checked.No patient involvement.

• Brand Name: CONSTRAINED TIBIAL ARTICULAR SURFACE PROVISIONAL SHIM SIZE GH 12 MM THICKNESS
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11286322
• MDR Text Key: 230622090
• Report Number: 0001822565-2021-00222
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 42527900602
• Device Lot Number: 62967513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/29/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1